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Ann Thorac Surg 2005;80:434-438
© 2005 The Society of Thoracic Surgeons
Division of Thoracic Surgery, Duke University Medical Center, Durham, North Carolina
Accepted for publication February 23, 2005.
* Address reprint requests to Dr D’Amico, Duke University Medical Center, Box 3496, Durham, NC 27710 (Email: damic001{at}mc.duke.edu).
Presented at the Fifty-first Annual Meeting of the Southern Thoracic Surgical Association, Cancun, Mexico, Nov 2–4, 2004.
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Abstract |
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METHODS: Two hundred and twenty-five tracheobronchial stents were placed in 172 patients for benign (n = 32) and malignant (n = 140) disease from January 1, 1997, to May 31, 2003. The records of the patients with malignant disease were retrospectively analyzed to determine complication rate, reintervention rate, and survival. The malignant diagnoses included nonsmall cell cancer, small cell cancer, esophageal cancer, and metastatic disease.
RESULTS: There were 172 stents placed in 140 patients with malignant disease, with no intraoperative mortality. The mean follow-up period was 142 ± 12 days. There were 23 complications, including tumor ingrowth (n = 9), excessive granulation tissue (n = 7), stent migration (n = 5), and restenosis (n = 2). Five of the complications occurred during the short-term period (<30 days) with the remaining complications (n = 18) occurring after 30 days. The complications required interventions including laser debridement (n = 14), dilation (n = 4), and stent removal (n = 5).
CONCLUSIONS: Tracheobronchial stents offer minimally invasive palliative therapy for patients with unresectable malignant central airway obstruction. The benefit of airway stents is particularly seen in the short-term period where they provide symptomatic improvement and have low complication risk. The major impediment is excessive granulation tissue and tumor ingrowth, which occur primarily after 30 days.
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Introduction |
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The impact of airway obstruction is significant with patients, in whom may develop dyspnea, pulmonary insufficiency, hemoptysis, postobstructive pneumonia, and complications associated with tracheoesophageal fistulas [4, 5]. The palliative interventions available include external beam radiation, brachytherapy, laser therapy, photodynamic therapy, cryotherapy, and stents. The effectiveness of stent placement—the ability to palliate malignant airway obstruction—is not universally accepted: patients may be denied interventional bronchoscopy or undergo therapies with less effectiveness. This study seeks to identify the short (<30 days) and intermediate (>30 day) benefits and risks of tracheobronchial stents in patients with malignant airway disease.
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Patients and Methods |
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Indications for intervention including known malignant central airway obstruction, the development of lobar collapse during or after treatment (chemotherapy or radiation therapy), acute or subacute changes in respiratory status not otherwise explained, or evidence of endobronchial disease amenable to palliation. The patients were treated with a total of 172 airway stents during this period, including flexible self-expanding metallic stents (n = 166) and rigid metallic stents (n = 6). Of the 140 patients, 47 patients had airway stents placed as outpatients whereas the remaining 93 patients were inpatients. Follow-up was performed using clinical criteria and repeated bronchoscopic procedures were performed only if patients had signs or symptoms of worsening disease, hemoptysis, or possible mechanical failure of their stent.
The primary diagnosis included nonsmall cell lung cancer (n = 107), small cell cancer (n = 9), lymphoma (n = 9), esophageal cancer (n = 8), and endobronchial metastatic disease (n = 7). The primary outcomes identified include short-term (<30 days) and intermediate-term (>30 day) complications, need for reintervention, and survival. The mean follow-up period for the patients was 142 ± 12 days.
Technique
Each airway stent was placed after the patient underwent general endotracheal anesthesia. The method of insertion of metallic stents is in accordance of previously reported stent implementation [6]. An introductory guidewire was first inserted across the lesion through the rigid or fiberoptic bronchoscope. Under fluoroscopic guidance, the stent delivery system was advanced, and the airway prothesis was then progressively deployed from its delivery catheter. Rigid metallic stents are placed over a guidewire with the use of fluoroscopy and deployed using a balloon.
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Results |
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Comment |
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TopAbstractIntroductionPatients and MethodsResultsCommentDiscussionReferences |
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The reports of complications associated with airway stents are largely based on stent type. Rubber or silicone stents require rigid bronchoscopy for placement. While correct placement is often difficult, the stents are easily removable. An additional benefit of silicone stents is that they maintain patency when placed as Y-shaped stents within the carinal and distal tracheal region, which is difficult given the anatomical location [8]. The main complications include a relatively high rate of dislodgement or migration and poor mucus clearance.
Self-expanding metal stents have replaced balloon-expandable rigid stents for airway obstruction. Recently, the development of self-expanding nitinol stents is reported to have improved on the previously reported complications [9]. Metallic stents are often considered as permanent because of the difficulty in repositioning and removing them. In addition, these stents may be complicated by excessive granulation tissue formation, and decreased mucocilliary clearance. Self-expanding stents are also available with a thin silicone cover, designed to prevent or inhibit tissue ingrowth through the body of the stent. These are particularly useful for management of malignant tracheoesophageal fistula, and they were used exclusively for this purpose in our series.
There are a number of series detailing the results of stenting for malignant central airway obstruction [10–14]. Wood and associates [10] recently reported results in 309 stent procedures, 67% for malignancy. In this series, all but 2 patients underwent rigid bronchoscopy, and 87% of stents placed were silicone rubber. Significant improvement was reported in 95% of patients, although 41% required multiple procedures to maintain this improvement. Complications from stenting occurred in 41% of cases, including stent migration and stent obstruction by granulation tissue or secretions; 28% required reintervention to maintain airway patency. Four patients sustained perforation, 1 of whom required thoracotomy for repair.
The current series represents a single-institution experience with the bronchoscopic management of malignant airway disease. In the present study, we demonstrate that the use of trachoebronchial stents in patients with malignant airway disease has a low, acceptable risk of complications at short and intermediate time points. At less than 30 days, only 5 of the 172 stents placed had complications compared with 18 of the stents after 30 days. The complications that did occur were primarily of bronchial stents, compared with tracheal stents. In addition, there was no predilection of complications based on specific location; however, the majority of the stents that failed were placed under severe extrinsic compression by tumor.
Overall, the patients treated with airway stents were not burdened by frequent reinterventions, as only 19 of the 140 patients required repeat procedures related to their stent. The median survival was 3.4 months, and 1-year survival was only 15% (Fig 1). However, that would not be unexpected in this population of patients with advanced stage disease. The median survival of only 3.4 months initiates the discussion of appropriate allocation of health care funds. Airway stent placement is a palliative procedure that was used primarily to improve symptoms of central airway obstruction. The patients did not return for frequent reintervention, and therefore the cost of their stents is comparable with other forms of palliative therapy, which often require repeat procedures.
Self-expanding metallic stents now constitute the majority of airway stents placed in our institution. Compared with rigid silicone stents, advantages include less migration, dynamic expansion, and simple insertion. In addition, uncovered stents have the theoretical benefit of neoepithelialization, incorporation of the stent into the airway, and maintenance of mucociliary clearance. Conversely, metallic stents are more prone to the development of excessive granulation tissue at proximal and distal ends, as well as decreased mucocilliary clearance. As a result of this risk, uncovered metal stents are used in patients with predominantly extraluminal compression while silicone-covered metallic stents may be favored in patients with intraluminal tumor [13]. Metal stents are considered permanent; however, it is possible to remove the stents if necessary, as demonstrated in this series.
Management of malignant airway disease includes comprehensive evaluation of resectability by general thoracic surgeons. Palliative therapy is reserved for unresectable patients. The optimal management of patients with unresectable malignant airway disease may include the use of radiation therapy, laser therapy, photodynamic therapy, and airway stents [14, 15]. Airway stenting has the ability to provide acute relief of central airway obstruction and to form a bridge until other therapy is effective. Secondly, airway stenting often plays a role as adjunctive treatment with other interventions including, laser ablation treatment. Similar to stenting, other palliative interventions have associated risks for complications. Bronchial dilatation is effective for some patients with intrinsic and extrinsic compression; however, results are not always sustained and often the mucosal trauma leads to granulation tissue formation and accelerates restenosis [15]. Furthermore, photodynamic therapy has received increased interest within recent years in managing patients with bulky airway tumors [16, 17]. However, concerns regarding the sloughing of necrotic tissue leading to airway occlusion and the need for further treatments have hindered the widespread application for this procedure. The symptomatic relief provided by airway stents in our patient population functioned as a bridge until further treatment could be used. Eighty-one percent (114 of 140) of patients in our cohort received some form of adjuvant therapy (chemotherapy or radiation therapy, separately or in combination). The added benefit of adjuvant therapy was documented in those patients who received radiation therapy after stent placement. The radiation treatment provided a significant increase in disease-free survival during the first year, although overall survival was not changed (Fig 2). Our findings are consistent with previous reports demonstrating no survival benefit for postoperative radiation therapy [18]. Adjuvant therapy with chemotherapy administered before and after stent placement also had no benefit.
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Discussion |
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I noticed in your study that you had 166 of these types of stents that expand, and I want to rise and say that those type of stents in benign disease should be condemned. I think you probably would agree. In malignant disease they are probably OK because of the low life expectancy of most of these patients, most of whom have esophageal cancer. I wondered if you have any experience with the new Polyflex, totally covered silastic stents that can be removed many years later. We have been using them exclusively now, not only for benign disease but also for patients with malignant disease as well. Have you gone to these newer stents that are a more difficult to put in, but are able to be removed long after insertion?
DR LEMAIRE: Thank you for your comments. At our institution we primarily use these self-expanding metallic stents that I have mentioned. I don’t have personal experience with their placement, but I do agree they do serve to have better benefit in terms of being more easily removed as opposed to the self-expanding stents, and less granulation tissue, as you mentioned, in stark comparison with the self-expanding metallic stents. So I do agree that they have added benefit. I don’t have any personal experience with their use.
DR JOSEPH I. MILLER (Atlanta, GA): I rise to congratulate you on a very nicely presented paper. It does raise several questions. You have just presented probably one of the largest series of stent placements reported anywhere in the country other than maybe one out of Boston. Secondly, I assume that you are defining central airway as either trachea or main stem for your stent placements.
Two years ago presented before this Society was our own series of palliative management of malignant airway obstruction. We offered four different varieties, but we rarely see the indication for a stent because the chemotherapy and radiation has become so good for malignant airway obstruction. I am amazed at your findings.
The other thing I rise to say, and I guess it is a question of human value, your mean survival was 3.4 months. There is almost hardly any patient we see with lung cancer with other types of management when you look at what the cost of the stent and the trip to the OR is, and again, it is a question of human value, but a mean survival of 3.4 months is really very short. Again, thank you for the opportunity of commenting.
DR LEMAIRE: Thank you for your questions. To answer your first question of using chemoradiation treatment as your main palliative therapy, what I did not include in the study was that 114 of the 140 patients actually did receive chemotherapy or radiation treatment, or both, in addition to their stent placement. So we do see a need and a use for chemotherapy or radiation treatment.
Regarding your second question, the mortality is high. I agree with you, 3.4 months is not a long time. We would never advocate stent placement to improve that, but to improve the quality of life, however, is what we are more focused on.
DR KEITH NAUNHEIM (St. Louis, MO): Doctor LeMaire, this was a nicely presented and impressive series. I want to echo what Joe Miller said. This is a great series, but I wonder if the next series shouldn’t include, if possible, quality of life questionnaires. These stents are not inexpensive. Reintervention for repeat bronchoscopy stent repositioning or replacement and the like is relatively frequent, and with just 3 to 4 months of survival, it is hard to imagine how much we are really helping. When you look at survival, the curve itself is asymptotic, and there are a number of people who went 3, 4, and 5 years, and they apparently did have significant benefit from the stents, but I wonder if you can in any way identify those patients who did survive 3, 4, and 5 years. And it may prove, if indeed you do a cost utility analysis, that it is going to be important to be able to pick those long-term survivors out. The patients who die within 2, 3, or 4 months probably receive minimal benefit. It is hard to know whether or not it is really going to be worthwhile expending the health care resources on those patients, and I wonder if you would like to comment on that.
DR LEMAIRE: Thank you very much. Actually we do have in place at this time quality of life questionnaires; however, the majority of the patients had not completed that when I performed the study, and therefore I didn’t want to make any conclusions based on half of the number of patients, but we have that in place as we speak.
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This article has been cited by other articles:
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  C. S. Chin, V. Litle, J. Yun, T. Weiser, and S. J. Swanson Airway Stents Ann. Thorac. Surg., February 1, 2008; 85(2): S792 - S796. [Abstract] [Full Text] [PDF]
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